Study:
A Phase I, Randomized, Double-Blind, Dose Escalation Trial of the Safety and Pharmacokinetics of a Single Intravenous Injection of I5NP in Patients at High Risk of Acute Kidney Injury Undergoing Major Cardiovascular Surgery
Rationale:
n/a
Purpose:
This is a Phase 1, randomized, double-blind, dose escalation, safety and pharmacokinetic
study. The study will be conducted in approximately 10 sites in the United States. Up to 48
patients at high risk for AKI (CCF score = 5 OR an estimated GFR (eGFR) <60 mL/min/1.73 m2)
who have undergone major cardiovascular surgery will participate. Patients will receive a
single IV injection of I5NP or placebo following cardiovascular surgery. I5NP will be
administered 4 hours (+/- 30 minutes) following removal of the cardiopulmonary bypass
machine (CBM).
The duration of the study is approximately 44 days, inclusive of a 14 day screening period.
Patients will be contacted by phone at 6 and 12 months for follow-up questions. Patient
visits are screening, day of surgery, hospital in-patient Days 1, 2, 3 - 5 and Day 7 or
hospital discharge. Safety follow-up will continue until 30 days post-surgery. 2 phone calls
will be made at 6 and 12 months after date of surgery.
Study Status: Terminated
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Acute Renal Failure
Acute Kidney Injury |
Drug: I5NP
Drug: Placebo |
Phase 1 |
Verified by
Quark Pharmaceuticals
November, 2010
Sponsored by: Quark Pharmaceuticals
Information provided by: Quark Pharmaceuticals
ClinicalTrials.gov identifier: NCT00683553
Study Type: Interventional
Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Martin S. Polinsky, M.D.., Study Director